CClinicalTrials.gg
Status unknownNCT02519465Updated Aug 11, 2015

Evaluation of Lung Deposition of Aerosol Via HFNC in Healthy Adults

An interventional study of 10l/min and 30l/min in Healthy, sponsored by Universidade Federal de Pernambuco. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-11.

Sponsored by Universidade Federal de Pernambuco · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The aerosol associated with noninvasive ventilation (NIV) and high flow therapy with nasal interface have been employed in an attempt to relieve respiratory distress and optimize the deposition of drugs by inhalation.

Some studies report the effects of NIV association with fogging in healthy subjects, asthmatics and COPD 7.8, but studies evaluating the association between high flow nasal mist interface and therapy are scarce and most are found in vitro and animal models. The objective of this study is to evaluate the deposition of the aerosol scintigraphy using the high flow nasal interface system with vibrating mesh nebulizers using in healthy adults.

02

Conditions studied

  • Healthy

Keywords

  • nasal cannula
  • Inhalation Devices
03

In context

Lead sponsor

Universidade Federal de Pernambuco is the lead sponsor of 161 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • The study included healthy individuals of both sexes,
  • between 18 to 65 years,
  • without history of lung disease and forced vital capacity (FVC) or forced expiratory volume in the first second (FEV1) higher or equal to 80% from predicted values,
  • ability to verbal commands understand and
  • willing to provide signed consent to participate in this study.

Exclusion criteria

Exclusion Criteria:

  • Participants were excluded if there unable to understand and follow the procedures and were pregnant and unable to tolerate nebulization.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
25 participants (estimated)

Study arms

  • Active comparator
    HEATED FLOW

    The volunteers were randomly allocated into three groups - group 1 - 10l/min cold or heated, group 2 - 30l/min cold or heated, group 3 - 50 l /min - cold or heatedPhase 1 - 10l/min or 30l/min or 50l/min of the oxygen heated .

    Other: 10l/min · Other: 30l/min · Other: 50l/min

  • Active comparator
    COLD FLOW

    The volunteers were randomly allocated into three groups - group 1 - 10l/min cold or heated, group 2 - 30l/min cold or heated, group 3 - 50 l /min - cold or heatedPhase 1 - 10l/min or 30l/min or 50l/min of the oxygen cold

    Other: 10l/min · Other: 30l/min · Other: 50l/min

Interventions

  • Other10l/min

    For inhalation was used diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) and 0.9% saline solution with a total volume of 1 ml using vibrating mesh inhaler (Aerogen Ltd, Galway , Ireland) with the respiratory care system for the high flow ( Fisher \& Paykel healthcare, New Zealand) and nasal cannula (Fisher \& Paykel healthcare, New Zealand) with flow 10l/min

  • Other30l/min

    For inhalation was used diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) and 0.9% saline solution with a total volume of 1 ml using vibrating mesh inhaler (Aerogen Ltd, Galway , Ireland) with the respiratory care system for the high flow ( Fisher \& Paykel healthcare, New Zealand) and nasal cannula (Fisher \& Paykel healthcare, New Zealand) with flow 30l/min.

  • Other50l/min

    For inhalation was used diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) and 0.9% saline solution with a total volume of 1 ml using vibrating mesh inhaler (Aerogen Ltd, Galway , Ireland) with the respiratory care system for the high flow ( Fisher \& Paykel healthcare, New Zealand) and nasal cannula (Fisher \& Paykel healthcare, New Zealand) with flow 50l/min.

06

What researchers measure

Primary outcomes

  1. radioaerosol deposition index into the lungs

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • Laboratório de Fisiologia e Fisioterapia Cardiopulmonar
    Recife, Pernambuco, Brazil
    Recruiting
08

References and documents

Publications

  • Alcoforado L, Ari A, Barcelar JM, Brandao SCS, Fink JB, de Andrade AD. Impact of Gas Flow and Humidity on Trans-Nasal Aerosol Deposition via Nasal Cannula in Adults: A Randomized Cross-Over Study. Pharmaceutics. 2019 Jul 7;11(7):320. doi: 10.3390/pharmaceutics11070320. PubMed 31284680 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02519465
Lead sponsor
Universidade Federal de Pernambuco
Responsible party
Daniella Cunha Brandao (Luciana Alcoforado Mendes da Silva, Universidade Federal de Pernambuco) — Principal investigator
First posted
Aug 11, 2015
Start date
Jul 2015
Primary completion
Aug 2015 (estimated)
Completion
Aug 2015 (estimated)
Last update
Aug 11, 2015

Study contacts

Daniella C Brandao, PhD
Contact
daniellacunha@hotmail.com
+558121268496
Armele F Dornelas de Andrade, PhD
Contact
armeledornelas@yahoo.com
+558121268496
Luciana Alcoforado, MsC
principal investigator · UFPE

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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